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Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts


N/A
18 Years
N/A
Open (Enrolling)
Female
Uterine Cervical Dysplasia

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Trial Information

Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Randomized Multicenter Study With Evaluation of Medico-economic Impacts


Inclusion Criteria:



- Women 18 years of age or older,

- Absence of contraindication to laparoscopy,

- Uterine cervical carcinoma (every histological type except neuroendocrine),

- Stage IA1 with lymphatic tumor space involvement (LVSI) or IA2 diagnosed on cervical
conization; or stage IA2, IB1 or IIA detected by clinical examination, confirmed by
biopsy and measured by the MRI, the highest diameter being lower to 4 cm (a
preoperative brachytherapy is allowed for tumors 2 to 4 cm in diameter),

- Negative pregnancy test for women able to procreate,

- Having the French National Social Security

- Signed informed consent

Exclusion Criteria:

- Neuroendocrine carcinoma,

- In situ carcinoma or stage IA1 without LVSI,

- Maximal tumoral diameter measured by MRI more than 4 cm,

- Stage IB1 by "down-staging",

- Stage IB2, IIB to IVB, including those who had a response to neoadjuvant treatment
(chemotherapy or RT + chemotherapy) ,

- Presence of distant metastases,

- Progression of the cervical cancer or recurrence,

- History of pelvic lymphadenectomy,

- Other cancer diagnosed during the course of treatment,

- Contraindication to the injected products : allergy known to Patent Blue or rhenium
sulfide,

- History of severe allergy (history of Quincke's edema, anaphylactic shock),

- Patient who does not understand, speak or write the French language,

- Pregnant woman

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants with complications observed in the 2 arms in the short-term (30 days after surgery)

Outcome Time Frame:

30 days after surgery

Safety Issue:

Yes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

2008.515

NCT ID:

NCT01639820

Start Date:

January 2009

Completion Date:

June 2013

Related Keywords:

  • Uterine Cervical Dysplasia
  • Cervical cancer
  • early stage carcinoma
  • FIGO IA1 IA2 IB1 IIA
  • sentinel lymph node biopsy
  • pelvic lymphadenectomy
  • Surgery of uterine cervical carcinoma
  • medico economic impact
  • quality of life
  • Uterine Cervical Neoplasms
  • Uterine Cervical Dysplasia
  • Cervical Intraepithelial Neoplasia

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